Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

Vigilance specialist lead provides scientific and medical input in support of Vigilance, Complaint Handling, and Non-Conformance issues related to Agilent marketed diagnostic products worldwide. In addition, they provide local and regional support for activities that require Agilent technologies to reach out to internal stakeholders, subsidiaries, distributors, authorities, notified body or legal partners of Agilent products.

Job Responsibilities -Issue evaluation

• Lead local and regional vigilance activities as requested and determined by the Enterprise Complaint Manager and/or the Medical Director
• Lead daily operation in terms of vigilance evaluations/escalations of NCRs and product investigation raised locally
• Organize and run local meetings to facilitate product investigations and any the execution of associated field actions/recalls
• Participate in CAPA activities related to vigilance and complaints.
• Provide daily support for cases that need to be evaluated and escalated for Vigilance reporting.
• Contribute to necessary updates to risk assessment documentation and support as required.
• Prepare/review data and research for input into metrics, trending and risk assessments.
• Draft Health Hazard Assessments and contribute to determination of Medical Device Reportability.
• Ensure product risk management files are updated to appropriately with known or new product risks to patient, user and/or handler.

Additional tasks in Complaints and Vigilance Team

• Process improvements projects
• Prepare/Review local activities supporting product investigations and vigilance documentation in accordance with procedures and regulatory requirements